TransCelerate Advances Industrywide Shift To Digital Protocols

Global stakeholders convene at TransCelerate's annual Digital Data Flow events; momentum builds through regulatory readiness, industry adoption, AI enablement, and ecosystem alignment

PHILADELPHIA, Oct. 8, 2025 /PRNewswire/ -- TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, today shared progress on its Digital Data Flow (DDF) initiative, reflecting the industry's growing readiness to embrace digital protocols and modernize clinical trials.

This growing momentum was evident at TransCelerate's recent DDF: Mission Possible! Practical Approaches for Protocol Digitalization events in the U.S. and Europe, where sponsors, regulators, and solution providers participated in interactive sessions on digital protocols, standards, and solutions. The sessions, held on September 24–25, reached capacity quickly across both locations with attendance numbers at an all-time high.

This year's progress builds on the June release of version 4 of the Unified Study Definitions Model (USDM), developed by Clinical Data Interchange Standards Consortium (CDISC) with TransCelerate's thought leadership and financial support. USDM v4 provides a standardized, machine-readable format for capturing clinical trial protocol information – creating a foundation for automation, interoperability, and data reuse across the trial lifecycle.

Despite industry advances, including the adoption of a common protocol template (first released by TransCelerate in 2015), today's clinical trial protocols are rarely fully digitized. An estimated 90% are created and managed as unstructured documents, slowing study start-up, requiring duplication of effort, and limiting both data reuse and patient access to key trial information. By converting protocols into structured, digital data, USDM v4 addresses these challenges and enables more connected, efficient trials.

"As an industry, we're seeing real momentum build around digital protocols," said Michelle Rohrer, Senior Vice President, Global Head of Product Development Regulatory, Roche and TransCelerate board member. "Sponsors are embracing DDF; implementation sets them up not only to comply with evolving regulatory specifications such as ICH M11 but also to improve efficiency and quality in regulatory documentation because data exchange is automated. We're also seeing more solution providers demonstrate innovation and efficiency through utilization of the standard and broad collaboration across the ecosystem. I have witnessed this progress over many years; I believe we are now at a turning point."

TransCelerate's DDF: Mission Possible! events align with several key factors driving industry adoption of digital protocols:

• Regulatory Readiness: Global regulators are signaling a shift toward structured, digital protocols. Early adopters of USDM are better positioned to align with guidance such as ICH M11 and prepare for digital-first submissions.
• Industry Implementation: Sponsors and solution providers across the ecosystem are adopting DDF, including the majority of TransCelerate's member companies, who collectively invest $125 billion annually in R&D.
• Ecosystem Momentum: Vendors, sponsors, and standards bodies are building on a common model, laying the groundwork for interoperability, analytics, and AI enablement.

"Digital protocols aren't just more efficient — they're transformational in their power to reshape how trials are executed," said Robert DiCicco, Vice President of Portfolio Management at TransCelerate BioPharma. "They create the opportunity for higher-quality data and a more connected ecosystem where insights can be shared and reused across the research community. Developing something that reflects inputs from a diverse group of stakeholders and is publicly available – all to advance the delivery of new medicines to patients – is the essence of TransCelerate."

To learn more about TransCelerate's Digital Data Flow initiative, visit https://www.transceleratebiopharmainc.com/initiatives/digital-data-flow/.

About TransCelerate BioPharma Inc.
TransCelerate BioPharma (TransCelerate) is a nonprofit organization that fosters collaboration across the global biopharmaceutical research and development community to simplify clinical trials and help bring new treatments to patients faster, safer, and more efficiently. Headquartered in the Philadelphia area, TransCelerate has 20 member companies and a robust portfolio of initiatives focused on transforming connectivity, enabling information sharing and reuse, and driving innovative trial designs. For more information, please visit transceleratebiopharmainc.com.

SOURCE TransCelerate BioPharma